Kornimate/medical-research-clean huggingface dataset:
continuous passive motion following fixation of pelvic and knee fractures

Conditions: Fractures, Bone

Summary: the investigators will directly compare the visual analog scale scores and narcotic pain medication requirements in the patients who have continuous passive motion (cpm) versus those who do not during the course of the hospital admission following an open reduction internal fixation surgery for acetabular fracture, supracondylar femur fracture, or a tibial plateau fracture.

this will be a prospective comparative cohort study analyzing the practices of three surgeons, one of whom routinely uses cpm following fixation of pelvic and acetabular fractures, and two surgeons who do not. all patients, over the age of 18 years who have undergone open reduction and internal fixation (orif) of isolated acetabular fractures, supracondylar femur fractures, or tibial plateau fracture will be asked to participate. those who consent will be randomized into two groups. the experimental group will have a cpm applied in the pacu immediately post-op and it will be utilized while the patient is awake in bed for 2 hours on and 2 hours off, when not mobilizing with physical therapy (pt). the experimental group will also have traditional pt, including sessions 1 to 3 times a week. the control group will have typical care, including working with physical therapy 1 to 3 times a week. the investigators will directly compare the vas scores and narcotic pain medication requirements in the patients who have cpm versus those who do not during the course of the hospital admission. vas scores will be assessed throughout the day by rn and/or pt. functional outcomes will be assessed at the one-year mark using the iowa and majeed pelvic functional outcome tools along with the sf-12. orthopedic resident or nurse clinical will check the patient for incision integrity each day and each session of using the cpm, the patient will be monitored for adverse events. data will be collected using epic. the investigators will record patient demographics including age, sex, and pre-existing narcotic usage. fracture type according to the orthopaedic trauma association will be recorded. vas scores and pain medication requirements will be recorded from the first 48 hours during the patient's stay. pain scores and cpm use will be obtained from epic using the flowsheet. functional outcomes will be assessed at the one-year mark using the iowa and majeed pelvic functional outcome tools along with the sf-12.

Eligibility criteria:
inclusion criteria: * age 18 or greater * isolated acetabular fractures, supracondylar femur fractures, or tibial plateau fracture * have undergone operative intervention for fracture exclusion criteria: * injury to either lower extremity that affects the patient's ability to weight bear * under the age of 18 * pregnant * a prisoner
interactive voice response (ivr) for methadone patients

Conditions: Opioid-Related Disorders

Summary: this study is designed to test whether a telephone call-in program is a feasible way to collect mood and drug-related information in individuals enrolled in a methadone maintenance program.

participants will complete a baseline interview and a follow-up interview at 5-weeks post-baseline. two-thirds of the participants will be randomized into the telephone call-in group, and will be asked to complete daily, 10-minute, telephone interviews. to complete these interviews, participants will call into a toll-free telephone interview system with a unique and private study id number, and answers questions by using the telephone key pad. questions during both the face-to-face interviews and the telephone interviews will assess mood, sleep, treatment utilization and drug-related experiences. participants will be compensated for their time. comparison(s): participants randomized into the telephone component of the study as compared to participants in the interview-only component of the study.

Eligibility criteria:
inclusion criteria: * recent enrollment in a methadone maintenance program exclusion criteria: * enrollment in a methadone maintenance program within the prior 3 months

Keywords: ivr, methadone methadone maintenance
characterizing postoperative t and b cell dysfunction in cancer surgery patients, using covid-19 as a model antigen

Conditions: Abdominal Cancer

Summary: the auer lab research program studies how surgery affects the immune system and how this can lead to suppression in cancer patients which can lead to cancer reoccurrence. this has been well characterized in literature, with a clear demonstration that both surgery induced suppression of t cell and natural killer (nk) cell result in cancer recurrence.. the present study is the first in humans, to our knowledge, to demonstrate antigen specific dysfunction in t cells and b cells following cancer surgery. the study capitalized on the widespread vaccination of cancer patients against covid before surgery, which allowed us to measure the response to the antigen s protein of sars-cov2. while the study is translational in methodology, we believe it will be of significant interest to all surgeons because it clearly establishes that surgery profoundly suppresses antigen-specific t and b cell responses, which have implications for postoperative infectious complications and cancer recurrence for those patients undergoing tumor resection


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of a primary abdominal malignancy consented to undergo major surgery with a planned length of stay of 3 or more days. * eligible patients must have signed a consent for surgical resection of the malignancy. * adequate hematological function defined as: platelet count ≥ 100 x 109/l, absolute neutrophil count ≥ 1 x 109/l, white blood count ≥ 2.5 x 109/l, hemoglobin count ≥ 90 g/l. * adequate organ functioning, including: total bilirubin ≤ 1.5 x upper limit of normal (uln); ast, alt \ 30ml/min. * ability to understand and provide a signed informed consent form (icf) approved by the institutional review board (irb/iec/reb). * ability to comply with protocol requirements. exclusion criteria: * documented significant immunodeficiency due to underlying illness (e.g. hiv/aids) and/or medication (e.g. systemic corticosteroids, azathioprine, cyclosporin a). subjects may be on physiologic doses of replacement prednisone or equivalent doses of corticosteroid (\<7.5 mg daily). * history of autoimmune disease (even if controlled with medication) such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. * allergies or any contraindication to the use of tadalafil or any components of cialis® or the influenza vaccine (including eggs), agriflu®. * serious intercurrent chronic or acute illness, or other illness considered by the investigator as an unwarranted high risk for an investigational product. * patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months. * patients with resting hypotension (bp \ 170/110 at rest). * patients with cardiac failure or coronary artery disease causing unstable angina.

Keywords: suppression
study to assess the immunogenicity, safety, and efficacy of high capacity process etanercept in rheumatoid arthritis subjects

Conditions: Arthritis, Rheumatoid

Summary: open-label immunogenicity, safety and efficacy study of etanercept manufactured using the high capacity process. descriptive results will be provided however a formal hypothesis will not be tested in this trial.


Eligibility criteria:
inclusion criteria: * moderate to severe active disease with presence of at least 4 tender joints and 4 swollen joints. * either the patient or a designee must be capable of administering the subcutaneous injection of study drug. exclusion criteria: * prior treatment with etanercept. * presence of active infection or active or untreated tuberculosis.
endoscopic ultrasound (eus) guided ethanol with paclitaxel ablation for pancreatic mucinous cystic neoplasm

Conditions: Mucinous Cystic Tumor With Moderate Dysplasia; Mucinous Cystadenoma of Pancreas; Mucinous Cystadenocarcinoma of Pancreas; Benign Neoplasm of Pancreas

Summary: pancreatic cysts are becoming diagnosed more frequently due to the increased use and sensitivity of imaging. a subset of these cysts are pre-cancerous, therefore suggested treatment is surgery for removal. however, surgery involves significant risks and emerging opinion suggests that not all cysts need to be surgically removed. an alternative therapy would be ideal, in particular for those where surgical risk outweighs the benefits of resection. ethanol and paclitaxel ablation of pancreatic cysts may be a viable alternative to surgical resection. our hypothesis is that ethanol with paclitaxel ablation is a safe and effective method for treatment in those with per-cancerous, mucinous pancreatic cysts.


Eligibility criteria:
inclusion criteria: 1. mucinous cystic neoplasm defined by cyst fluid analysis \[23, 28\]: * cea \> 192ng/ml * amylase \< 800 iu/l * cytology negative for malignant cells * no communication of cyst with pancreatic duct on 2 imaging studies (eus, ct, mrcp, or ercp) 2. cyst size \> 15mm but \<50mm 3. 3 or fewer cyst compartments 4. age ≥18 and ≤ 85 exclusion criteria: 1. inability to safely undergo eus examination with standard conscious sedation 2. inability for safe fna needle insertion into the cyst (eg: intervening vessel) 3. inability to undergo mri (metal implants/cardiac pacemaker/defibrillator, claustrophobia) 4. coagulopathy (inr\>1.5 or platelets\<50) 5. active pancreatitis or pancreatic infection 6. active sepsis/bacteremia 7. inability to provide informed consent 8. pregnancy 9. breastfeeding women

Keywords: endoscopic ultrasound pancreatic mucinous cystic neoplasm fine needle injection ethanol ablation paclitaxel ablation
palliative radiochemotherapy against palliative surgery in stage iv rectal cancer with unresectable metastases

Conditions: Rectal Cancer

Summary: short course palliative radiotherapy (5x5gy)to the pelvis in patients with symptomatic rectal tumours and with unresectable metastases may prevent palliative surgery with a good palliative outcome.the consolidating chemotherapy of xelox may increase the efficacy of irradiation.

patients with symptomatic rectal cancer and unresectable metastases receive 25 gy in 5 fractions of 5 gy over 5 days to the pelvis and xelox consolidating chemotherapy after one week. investigators arbitrarily assumed that palliative radiotherapy to the pelvis can replace the immediate surgery if at least 30% of patients would avoid delayed surgery until the end of their lives, or for at least 18 months in the case of long-term survival.

Eligibility criteria:
inclusion criteria: * histologically confirmed primary carcinoma of the rectum (lower border of tumour ≤ 10 cm from anal verge) * occurrence of subjective clinical symptoms of the primary tumor * non-resectable synchronous distant metastases. the decision of non-resectable metastases will be made at multidisciplinary clinical meetings. exclusion criteria: * obstruction of the gastrointestinal tract * previously constructed stoma * prior radiotherapy of the pelvis

Keywords: rectal cancer unresectable synchronous metastases pelvic radiochemotherapy
study of memantine in assessment of selected measures of volumetric magnetic resonance imaging (mri) and cognition in moderate ad (alzheimer's disease)

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to characterize the progression of disease using volumetric mri techniques and cognitive outcome measures in patients with moderate dementia of the alzheimer's type treated with open-label memantine.


Eligibility criteria:
inclusion criteria: * ambulatory male or female patients at least 50 years of age (females at least 2 years postmenopausal) * a diagnosis of probable ad \[according to the national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders associations (nincds-adrda) criteria\] of moderate severity \[mini-mental state examination score between 15 and 20, inclusive\] * on a stable dose of food and drug administration (fda)-approved acetylcholinesterase inhibitor exclusion criteria: * current diagnostic and statistical manual of mental disorders-fourth edition (dsm-iv) axis i disorder other than ad * previous imaging results not consistent with the diagnosis of ad * modified hachinski ischemia score greater than 4 * evidence of other neurologic disorders * inability to participate in mri testing * no clinically significant systemic disease * a known or suspected history of alcohol or drug abuse in the past 10 years * taking excluded medication * previous treatment with commercial memantine

Keywords: memantine alzheimer's disease mri moderate alzheimer's disease
a post marketing surveillance (pms) study to monitor the safety of glaxosmithkline (gsk) biologicals' human papillomavirus (hpv) vaccine in female chinese subjects

Conditions: Cervical Intraepithelial Neoplasia

Summary: the purpose of this prospective, multi-centre, pms cohort study was to monitor the safety of cervarix, which is the first hpv vaccine licensed for use in china, to help prevent cervical cancer caused by hpv types 16 and 18. the vaccine was approved by national drug administration of china (cnda), in july 2016. as per the cnda commitment, this study collected data regarding the safety of the vaccine, related information on potential immune-mediated diseases (pimds); which are diseases that could affect the immune system, and the effect on pregnancy outcomes (pos) including birth defects in the newborn. cervarix was approved for use in females between 9-25 years of age, for the prevention of cervical cancer, cervical intraepithelial neoplasia grade 1 (cin1), cervical intraepithelial neoplasia grade 2, grade 3 (cin 2/3) and adenocarcinoma in situ caused by high-risk human papillomavirus (hr-hpv) types 16 and 18. in may 2018, cervarix was also approved for use in women of age up to 45 years. the exposed set (es) comprised 3013 subjects, who were vaccinated with cervarix, on a voluntary basis, as per standard practice. the study collected information on any adverse event following immunisation, pimds, pos and congenital anomalies.


Eligibility criteria:
inclusion criteria: * any chinese female subject aged between 9 and 45 years, at the time of first vaccination dose, who received voluntary vaccination. * subjects for whom the investigator believed that they or their parent(s)/lar(s) could and complied with the requirements mentioned in the protocol (e.g., return for the subsequent dose of vaccination and follow-up visits) were included in the study. * written informed consent was obtained from the subject. for subjects who were below the legal age of consent, written informed consent were obtained from the parent(s)/lar(s) of the subject and informed assent were obtained from the subject according to ec requirement as well as local law. exclusion criteria: • child in care

Keywords: safety human papillomavirus vaccine adverse event following immunization
resting full-cycle flow ratio (rfr) versus angiography to guide revascularization strategy in patients undergoing coronary artery by-pass grafting (cabg)

Conditions: Coronary Artery Disease

Summary: different trials have shown that fractional flow reserve (ffr) could successfully guide revascularization in patients undergoing percutaneous coronary intervention (pci). it is conceivable that a similar revascularization guidance could be useful also for surgical revascularization i.e. coronary by-pass graft (cabg). experience learns that grafts placed on vessels with hemodynamically non-significant stenosis often occlude due to competitive antegrade flow. resting full-cycle flow ratio (rfr) is a measurement performed to evaluate the hemodynamic severity of coronary stenosis. differently from ffr which is a measurement performed in maximal hyperemia, the rfr is a measurement that is performed in rest and therefore may predict better than ffr the baseline equilibriums that could lead to graft failure, while it has similar capacity to identify hemodynamically significant stenosis as ffr. it is unknown whether rfr guided cabg revascularization is superior as compared to angiography alone.


Eligibility criteria:
inclusion criteria: * all patients between 18 or older undergoing cabg * patients willing and capable to provide written informed consent exclusion criteria: * previous cabg * concomitant severe valvular disease intervention * remaining (expected) coronary stenosis of \> 50% diameter stenosis distally to graft anastomosis * left ventricular ejection fraction \<30% * known transmural myocardial infarction * documented microvascular disease * rfr/ffr measurement judged impossible * life expectancy \<2 years * participation in other investigational clinical trials

Keywords: rfr guided cabg angiography guided cabg graft dysfunction
effect of combined therapy on neglect syndrome in stroke patients

Conditions: Cerebrovascular Accidents

Summary: the purpose of the current study is to evaluate motor and neglect recovery of stroke patients produced by cit using kinematic and oculomotor assessment, together with conventional clinical measures.

this project will be carried out using a short term constraint and training protocol targeting at subacute and chronic patients with motor and perceptual deficits. the outcome measures will include kinematic and oculomotor analyses, which have not been employed yet.

Eligibility criteria:
inclusion criteria: * a clinical cerebrovascular of right cerebral accident patients * the age over 18-year-old * demonstration of brunnstrom stage iii of the affected upper extremity * patients with perceptual deficits * no severe cognitive disorder, could understand and follow orders * no severe equilibrium problems which will influence the intervention exclusion criteria: * recurrent of the stroke or epilepsy during the intervention * patients with the neurological or psychical history, for example, alcoholism, drug poisoning or bipolar disorder * injected the botox into the affected upper extremity during the past 6 months * participate in the other interventional study in the same time * refuse subscribed the informed consent

Keywords: stroke rehabilitation perceptual deficits kinematic analysis
the efficacy and safety of third-generation tkis combined with azacitidine and bcl-2 inhibitor in patients with cml-mbp

Conditions: Chronic Myeloid Leukemia

Summary: this is a prospective multi-center study to investigate efficacy and safety of the third generation tyrosine kinase inhibitors (tkis) combined with azacitidine and b-cell lymphoma-2 (bcl-2) inhibitor in patients with myeloid blast phase chronic myeloid leukemia (cml-mbp).

cml-mbp has dismal outcome. currently, there is no standardized induction treatment approach in cml-mbp. the european leukemianet (eln) recommendations and nccn guideline recommended the combination of tki and chemotherapy in cml-mbp. the previous study revealed that tki combined with hypomethylating agents had promising efficacy. however, imatinib and second generation tki are the most widely applied in combination treatment, there is limited data in third generation tki. currently, venetoclax in combination with hypomethylating agents such as azacitidine is standard treatment for patients with aml unsuitable for intensive induction chemotherapy. maiti et al. reported that tki combined with venetoclax and detectable had promising efficacy in cml-mbp. therefore, the investigator conducted a study to explore the efficacy and safety of a third generation tki in combination with azacitidine and bcl-2 inhibitor in cml-mbp and multi-omics exploratory analysis was performed to identify potential biomarkers correlated with the outcome.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old; 2. philadelphia chromosome (ph)-positive or bcr::abl-positive; 3. serum creatinine ≤ 1.5 × upper limit of normal (uln) or 24h creatinine clearance ≥ 50 ml/min when serum creatinine was \&gt; 1.5 × uln; 4. serum total bilirubin ≤ 1.5 × uln; 5. aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × uln; 6. amylase ≤ 1.5 × uln; (7) lipase ≤ 1.5 × uln; 7. ejection fraction \&gt; 50%; corrected qt interval on electrocardiographic evaluation was ≤ 450 ms in men or ≤ 470 ms in women. exclusion criteria: 1. concurrent diseases requiring treatment(s) with potential to interact with 3g-tki; 2. diagnosis of other primary malignancies; 3. history of allogeneic hsct; 4. extramedullary disease only.
prevention and treatment of differentiation syndrome in patients with acute promyelocytic leukemia

Conditions: Safety and Efficacy

Summary: with the introduction of all-trans-retinoic acid (atra) and arsenic,the outcome of patients with acute promyelocytic leukemia (apl)has been improved considerably over the last decades.however，early deaths (eds), mainly due to apl-specific coagulopathy, differentiation syndrome (ds)emerge as a major threat to apl patients.we observe and evaluate the effectivity of induction therapy in patients with apl. administrate intravenous dexamethasone to prevent or preemptive treat ds. assess the efficacy and safety of ruxolitinib as second treatment in patients with severe ds with no respond to dexamethasone.furthermore，the changes of spectrum of cytokines are monitered to find the relationship between the cytokines and the severity of ds.

adults ages 18-75 with primary acute promyelocytic leukemia. design: the induction therapy with atra 25mg/m2/d and ato 10mg/kg/d should be started as soon as the diagnosis of apl confirmed. intravenous dexamethasone at a dose of 5-20 mg daily must be started if the wbc count greater than 5e+9/l (before or during the treatment with atra) as prevention or preemptive therapy of ds. idarubicin (4-10 mg/m2 /d\*3d) and hydroxyurea（1.0-3.0g/d）can be given as leukocyte lowering therapy which may lessen the risk of ds. when the progression of clinical symptoms of ds with no response to dexamethasone,atra must be stopped and ruxolitinib (5-20mg /d) should be administrated to reduce the production of cytokines. participants should stay in the hospital during the treatment for about 4 weeks. the changes of spectrum of cytokines are monitored to discover the potential relationship between the cytokines and the severity of ds. participants will visit every 1 months after cr for 3 years.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of primary acute promyelocytic leukemia. * ecog score≤3. * must be able to understand and willing to participate in the study and sign the informed consent. exclusion criteria: * refractory/secondary acute promyelocytic leukemia. * severe complications such as myocardial infarction, chronic cardiac insufficiency, hepatic failure, renal insufficiency, etc. * clinically uncontrolled active infections. * malignant tumors with other progresses. * ecg: qt interval \> 450 ms. * allergic to arsenic agent. * pregnant or lactating women.
a study for patient with chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the purpose of this study is to determine if duloxetine reduces the severity of chronic low back pain.


Eligibility criteria:
inclusion criteria: * male or female outpatients with chronic low back pain exclusion criteria: * cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study. * acute liver injury (such as hepatitis) or severe cirrhosis. * previous exposure to duloxetine. * body mass index (bmi) over 40. * major depressive disorder. * daily use of narcotics.